Psychological Burden of Thyroid Eye Disease

NCT07444190 | Completed

• 1 other identifier: iRISID-2024-3013
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This interview study aims to look in depth at the quality of life of people living with TED and their caregivers, with emphasis on impact on mood, relationships, work/education, and leisure. The investigators plan to examine this through a two-part focus group followed by individual interviews. Participants will also complete self-report measures.

Conditions

Thyroid Eye Disease, TED

Keywords

TED, thyroid eye disease

Outcome Measures

Primary Outcomes (1)

• Understand the experience of people living with TED and of caregivers of people living with TED. The investigators aim to define the different facets of TED-specific psychological burden.

  Understand the experience of people living with TED and of caregivers of people living with TED. Through semi-structured individual interviews, focus groups, polls during focus groups, and completion of a battery of standardized self-report measures of depressive symptoms (Beck Depression Inventory-II, Patient Health Questionnaire - 9), anxiety (Generalized Anxiety Disorder -7, Beck Anxiety Inventory), value-based living (Valued Living Questionnaire), and psychological flexibility (cognitive fusion questionnaire -13, acceptance and action questionnaire-2), the investigators aim to define the different facets of TED-specific psychological burden as experienced by patients and by loved ones of people living with TED.

  3 months

Study Arms (1)

patients living with TED and their loved ones

interviews, focus groups \& completion of questionnaires by patients living w TED and their loved ones

Other: focus groups and individual interviews as well as filling out questionnaires

Interventions

focus groups and individual interviews as well as filling out questionnaires OTHER

focus groups and individual interviews as well as filling out questionnaires

patients living with TED and their loved ones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with TED and their loved ones

You may qualify if:

• Age 18 and older
• Clinical diagnosis of Thyroid Eye Disease (patients) OR serving in a caregiving role for someone with a clinical diagnosis of Thyroid Eye Disease (caregivers)

You may not qualify if:

• Inability to consent or to engage in treatment in English
• Presence of psychotic disorder or symptoms
• Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician.
• Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Amgen: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 2, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 10/1/2025-12/31/2025
• Access Criteria: patrick smith, phd mph for statistical analyses

Locations

US (1)